Long Term Impact of COVID-19

Long Term Sequelae of COVID-19: Observational Cohort Study in Twente, the Netherlands

COVID-19, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, has a devastating effect on human lives, including over 6.6 million death as of November 2022. Furthermore, many individuals continue to experience persisting sequelae after the initial infection. Little is known about the impact of undergoing COVID-19 hospitalisation. Hence, the investigators propose an observational longitudinal study in a cohort of COVID-19 survivors after hospital discharge, to examine their perspectives on their health, health-related quality of life, and persistence of common COVID-19 symptoms, such as fatigue, dyspnoea and anxiety. Potential influencing socio-demographic and biological factors will additionally assessed.

Study Overview

• Status: Completed
• Conditions: COVID-19; Post-COVID-19 Syndrome; Long COVID-19
• Intervention / Treatment: Other: Observational patient reported outcomes

• Study Type: Observational
• Enrollment (Actual): 835

Contacts and Locations

Study Locations

• Netherlands
  • Overijssel
    • Enschede, Overijssel, Netherlands, 7512KZ
      • Medisch Spectrum Twente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients (≥18 years old) with SARS-CoV-2 infection confirmed by PCR, and hospitalised and subsequently discharged from MST or ZGT hospital

Description

Inclusion Criteria:

• Ages ≥18 years
• PCR-confirmed SARS-CoV-2 infection and hospital admission
• Proficiency in Dutch
• Providing informed consent

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 survivors; COVID-19 survivors: patients (≥18 years old) who were tested positive for SARS-CoV-2 infection as confirmed by polymerase-chain-reaction (PCR) testing and were subsequently hospitalised, were followed after discharge from hospitals in Enschede (MST), Hengelo or Almelo (ZGT).	Other: Observational patient reported outcomes; Of COVID-19 patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General health perception	measured by Short Form 36 Health Survey (SF-36)	at 12 months after hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence, severity and course of Post-Traumatic Stress Disorder	measured by PTSD checklist for th DSM-5 (PCL-5) COVID-19 version	at 3, 6, 9 and 12 months
Health-related quality of life	measured by Short Form 36 Health Survey (SF-36). Physical role limitations, bodily pain, general health perceptions vitality, social functioning, emotional role limitations and mental health. Min=0, Max=100 where higher scores indicate better health outcomes	at 3, 6, 9 and 12 months
Health Status	measured by EuroQol 5d(EQ-5D). Mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Min = 1, Max = 5, where higher scores indicate worse health outcomes.	at 3, 6, 9 and 12 months
Health Status Scale	Measured by EQ Visual Analogue Scale for self-rated health. Min = 0, Max = 100, where higher scores indicate better health outcomes.	at 3, 6, 9 and 12 months
Positive Health	measured by my Positive Health]): Min = 0, Max = 10, where higher scores indicate better health outcomes	at 3, 6, 9 and 12 months
Incidence, severity and course of Fatique	measured by Short Fatique Questionnaire; min = 4, max = 28, higher scores indicating worse fatigue]	at 3, 6, 9 and 12 months
Incidence, severity and course of Dyspnoea	measured by modified Mental Research Council (mMRC) scale; min = 1, max = 6, higher scores indicating worse dyspnoea	at 3, 6, 9 and 12 months
Incidence, severity and course of Sleep	measured by unvalidated single-item question min = 1, max = 5, higher scores indicating worse sleep	at 3, 6, 9 and 12 months
Experience sampling study measuring fatigue	Fatigue (physical, and mental), 1-7, as single-item with higher scores indicating worse health outcomes	Six times a day over 14 days
Experience sampling study measuring dyspnoea	Dyspnoea (1 - 7), as single-item with higher scores indicating worse health outcomes	Six times a day over 14 days
Experience sampling study measuring cognitive functioning	cognitive functioning, 0 - 10, as single-item with higher scores indicating worse health outcomes	Six times a day over 14 days
Experience sampling study measuring pain	pain (headache, joint pain, chest pain or discomfort, and pain elsewhere/non-specific; 0 - 10, as single-item with higher scores indicating worse health outcomes	Six times a day over 14 days
Experience sampling study measuring severity and daily course of positive and negative affect	Positive (excited, relaxed, satisfied, thankful, and happy) and negative (anxious, gloomy, sad, irritable, and disappointed) affect (all single-items; 1 - 7, higher scores indicating better and worse outcomes for positive and negative affect respectively	Six times a day over 14 days
Experience sampling study measuring daily activity	Type of activity just before measurement; o Options: 1: nothing; 2: strenuous relaxation (for example walking, riding a bike, gardening); 3: passive relaxation (for example watching television, reading a book); 4: sleeping or resting; 5: Work/study; 6: household chores; 7: Eating/drinking; 8: self-care (for example bodily hygiene, medication); 9: On the go; 10: social interaction; 11: Something else, namely…	Six times a day over 14 days
Experience sampling study measuring sleep	Sleep (quality and duration) ; single-item; How many hours of sleep did you get last night?	Once a day for 14 days
Experience sampling study measuring naps	naps (frequency and duration; single-item	Once a day for 14 days
Experience sampling study measuring health status	Self-reported health status (EQ-VAS of the EQ-5D-5L; 0 - 100; higher scores indicating better health outcomes)	Once a day for 14 days

Collaborators and Investigators

• Sponsor: Medisch Spectrum Twente
• Collaborators: Ziekenhuisgroep Twente; University of Twente
• Investigators: Principal Investigator: Harald E. Vonkeman, PhD, Medisch Spectrum Twente

Publications and helpful links

General Publications

• Wensink M, Schaap G, Ten Klooster PM, Doggen CJM, van der Palen J, Vonkeman HE, Bode C. Physical and mental fatigue in post-COVID syndrome and their associations over time: A small-sample ESM-study to explore fatigue, quality of sleep and behaviours. J Psychosom Res. 2023 Jan;164:111084. doi: 10.1016/j.jpsychores.2022.111084. Epub 2022 Nov 17.
• Schaap G, Wensink M, Doggen CJM, van der Palen J, Vonkeman HE, Bode C. "It Really Is an Elusive Illness"-Post-COVID-19 Illness Perceptions and Recovery Strategies: A Thematic Analysis. Int J Environ Res Public Health. 2022 Oct 11;19(20):13003. doi: 10.3390/ijerph192013003.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2020
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: Long COVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No